Engaging element for engaging tissue

ABSTRACT

An engaging element for engaging tissue that includes a first member and a second member. The first member includes at least one tissue engaging portion at a first free end. The first tissue engaging member is movable between an open position and a closed position and has a second free end. The first tissue engaging member is restrained in movement at an intermediate position between the first free end and the second free end. A lock portion is operatively associated with the first member with the lock portion maintaining a spacing between the first member and the second member and inhibiting movement of the first member to the open position. The lock portion is operatively associated with a portion of the first tissue engaging member proximal the intermediate position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/122,603, filed May 16, 2008, entitled “Apparatus and Methods forEngaging Tissue”, the entirety which is incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and moreparticularly to apparatus and methods for engaging tissue.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guidewire may beadvanced through the needle and into the patient's blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guidewire into the vessel, e.g., in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guidewire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath areremoved, leaving a puncture site in the vessel wall. Traditionally,external pressure had often been applied to the puncture site untilclotting and wound sealing would occur; however, the patient must remainbedridden for a substantial period of time after clotting to ensureclosure of the wound. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. Another technique has been suggested thatinvolves percutaneously suturing the puncture site, such as thatdisclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forinstance, U.S. Pat. No. 5,676,689, issued to Kensey et al., discloses ableed back lumen intended to facilitate positioning of a biodegradableplug within a puncture site. This device, however, requires that ananchor of the plug be positioned within the vessel, and therefore, mayincrease the risk of over-advancement of the plug itself into thevessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand in order to engagethe inner wall of the vessel, thereby facilitating holding the sheath ina desired location with respect to the vessel.

Accordingly, additional apparatus and methods for engaging tissue wouldbe useful.

BRIEF SUMMARY

An embodiment of an engaging element for engaging tissue is described.The engaging element includes a first member having at least one tissueengaging portion. The engaging element includes a second member havingat least one tissue engaging portion and being pivotally connected tothe first member. The engaging element includes a locking mechanism thatis operatively associated with the first and second member. The lockingmechanism is configured to inhibit the relative motion of the first andsecond member.

An embodiment of an engaging system for engaging tissue is described.The engaging system includes an engaging element for engaging tissue.The engaging element includes a first member having at least one tissueengaging portion. The engaging element also includes a second memberincluding at least one tissue engaging portion. The second member ispivotally connected to the first member. The engaging element furtherincludes a locking mechanism operatively associated with the first andsecond member. The locking mechanism is configured to inhibit therelative motion of the first and second member. The engaging system alsoincludes an engaging element delivery device. The engaging elementdelivery device includes a transitioning member. The transitioningmember is configured to transition the engaging element from an openconfiguration toward a closed configuration.

A method for engaging tissue is described. The method includespositioning an engaging element relative to an engaging element deliverydevice. The engaging element includes a first member having at least onetissue engaging portion. The engaging element also includes a secondmember having at least one tissue engaging portion. The second member ispivotally connected to the first member. The engaging element furtherincludes a locking mechanism operatively associated with the first andsecond member. The locking mechanism is configured to inhibit therelative motion of the first and second member. The engaging elementdelivery device includes a retaining member. The retaining memberincludes a retaining mechanism and a transitioning member. The engagingelement is positioned relative to a portion of tissue. A portion of thetissue is engaged with at least one tissue engaging portion. Theengaging element is transitioned from an open configuration toward aclosed configuration using the transitioning member. A locking mechanismis activated using the transitioning member to inhibit the relativemotion of the first member and the second member.

In some embodiments of an engaging member, the first and second memberinclude a proximal end. In further embodiments of an engaging member,the proximal ends of the first member and second member are separated bya first transitioning dimension in an open configuration and a secondtransitioning dimension in a closed configuration.

The first transitioning dimension, in some embodiments of an engagingmember, is larger than said second transitioning dimension. In otherembodiments of an engaging member, the first transitioning dimension issmaller than said second transitioning dimension. In further embodimentsof an engaging member, the locking mechanism includes a first lockingportion and a second locking portion, such that movement of the at leastone tissue engaging portions of the first and second members isinhibited by the operative association between the first and secondlocking portions.

In some embodiments of an engaging member, the first locking portionincludes at least one tooth associated with the first member and thesecond locking portion includes a locking member associated with thesecond member. In other embodiments of an engaging member, the lockingmember is biased toward the at least one tooth.

The locking member and the at least one tooth, in some embodiments of anengaging member, inhibit the at least one tissue engaging portions ofthe first and second members from moving toward the open configuration.In further embodiments of an engaging member, the first locking portionincludes a latch associated with the first member and the second lockingportion includes a latching portion associated with the second member.In still further embodiments of an engaging member, the latch and thelatching portion inhibit the at least one tissue engaging portion of thefirst and second members from moving toward the open configuration.

In some embodiments of an engaging member, at least one tissue engagingportion of the first member and the at least one tissue engaging portionof the second member are separated by a first distal dimension in anopen configuration and are separated by a second distal dimension in aclosed configuration. The first distal dimension is larger than thesecond distal dimension, in some embodiments of an engaging member.

The engaging element, in some embodiments, includes a pivoting mechanismoperatively associated with the first and the second members. In furtherembodiments of an engaging member, the pivoting mechanism includes apivoting opening associated with one of the first member and the secondmember and a pivoting member associated with the other of the firstmember and the second member.

In some embodiments of an engaging member, the engaging element furthercomprises a retaining portion configured to be operatively associatedwith a retaining mechanism. In further embodiments of an engagingmember, the engaging element includes bioabsorbable, biodegradable,and/or bioerodible material. In still further embodiments, the engagingelement includes collagen, polycaprolactone (PCL), poly-D,L-lactic acid,Poly-L-lactic acid, poly (lactide-co-glycolide), poly(hydroxybutyrate),polyanhydrides, and/or poly(glycolic acid).

The engaging element, in some embodiments of an engaging system,includes a pivoting mechanism operatively associated with said first andsaid second member. Further embodiments of an engaging system include aretaining member that has a retaining mechanism configured to selectablyinhibit the relative motion of said engaging element and said retainingmember.

In some embodiments of an engaging system, a pivoting mechanism includesa pivoting opening associated with one of the first and second memberand a pivoting member associated with the other of the first and secondmember. In further embodiments of an engaging system, the retainingmechanism is operatively associated with the pivoting opening toselectably inhibit the relative motion of the engaging element and theretaining member. In still further embodiments of an engaging system,the retaining mechanism includes a retaining detent that engages thepivoting opening to selectably inhibit the relative motion of theengaging element and the retaining member.

The retaining member and the transitioning member, in some embodimentsof an engaging system, are axially aligned. In further embodiments of anengagement system, the retaining member is configured to slidablyreceive the transitioning member.

In some embodiments of an engaging system, the first and second memberof the engaging element include a transitioning portion. Thetransitioning member, in further embodiments, includes a transitioningsurface that is shaped to engage with the transitioning portion of atleast one of the first and second member of the engaging element. Insome embodiments, the transitioning surface has a convex shape. In otherembodiments, the transitioning surface has a concave shape.

Some embodiments of a method for engaging tissue include selectablyretaining the engaging element using a retaining mechanism to inhibitthe relative motion of the engaging element and the retaining member.Further embodiments of a method for engaging tissue include disengagingthe locking mechanism.

Other aspects and features of the present invention will become apparentfrom consideration of the following description in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention will be rendered by reference tospecific embodiments thereof which are illustrated in the appendeddrawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered tobe limiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings.

FIG. 1A is a perspective partial cutaway view of an embodiment of asystem for engaging tissue with an engaging element in an openconfiguration, according to an embodiment of the present invention.

FIG. 1B is a perspective partial cutaway view of the embodiment of asystem for engaging tissue of FIG. 1A with an engaging element in aclosed configuration, according to the present invention.

FIG. 1C is a top cutaway view of the embodiment of the system forengaging tissue of FIG. 1A, according to the present invention.

FIG. 2A is a perspective view of another embodiment of an engagingelement in an open configuration, according to the present invention.

FIG. 2B is a perspective view of the embodiment of the engaging elementof FIG. 2A in a closed configuration, according to the presentinvention.

FIG. 2C is a perspective view of an embodiment of a system for engagingtissue with the embodiment of the engaging element of FIG. 2A in an openconfiguration, according to the present invention.

FIG. 2D is a perspective partial cutaway view of the embodiment of asystem for engaging tissue of FIG. 2C with the embodiment of theengaging element of FIG. 2A in a closed configuration, according to thepresent invention.

FIG. 2E is a right cutaway view of the embodiment of the system forengaging tissue of FIG. 2C with the embodiment of the engaging elementof FIG. 2A in an open configuration, according to the present invention.

FIG. 2F is a right cutaway view of the embodiment of the system forengaging tissue of FIG. 2C with the embodiment of the engaging elementof FIG. 2A in a closed configuration, according to the presentinvention.

FIGS. 3A-3K illustrate various steps in the deployment of an embodimentof an engaging element to engage tissue according to one example.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike-reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of embodiments of the present invention.

DETAILED DESCRIPTION

Embodiments described herein extend to methods, systems, and apparatusfor engaging tissue. Some embodiments may be used to close and/or sealopenings in a blood vessel or other body lumen formed during adiagnostic, therapeutic, and/or other procedure. The engaging elementsof the present invention may be configured to be delivered throughtissue and into an opening formed in and/or adjacent to a wall of ablood vessel or other body lumen. The engaging elements provided hereinmay reliably engage.

Moreover, the engaging elements may be made of any suitable material,including a bioabsorbable material, such as collagen. Otherbiodegradable materials may include polycaprolactone (PCL),poly-D,L-lactic acid, Poly-L-lactic acid, poly (lactide-co-glycolide),poly(hydroxybutyrate), polyanhydrides, poly(glycolic acid, and/or otherbiodegradable materials.

Referring generally to FIGS. 1A-1C, the system 100 may include anengaging element 110 and an engaging element delivery device 160. Theengaging element 110 may include a first member 112 and a second member114. The first member 112 and the second member 114 may include tissueengaging portions 116 (three tissue engaging portions 116 on each of thefirst member 112 and the second member 114, in the present embodiment).The tissue engaging portions 116 may include a sharpened tip, as shown,and/or may include other tips, such as barbed tips. The tissue engagingportions 116 may be configured to engage tissue.

The engaging element delivery device 160 may include a retaining member164, a transitioning member 168, a carrier member 172, a locator 176,and/or other components. The transitioning member 168 may include alumen. The lumen may receive the carrier member 172, the locator 176,and/or other components. The carrier member 172 may be configured toreceive a locator 176 and/or other components.

The engaging element 110, locator 176, carrier member 172, transitioningmember 168, and/or retaining member 164 may be axially aligned. Thecarrier member 172 and/or locator 176 may be configured to fit within achannel of the engaging element 110 in the open configuration.

The first member 112 and second member 114 may be pivotally connected.The first member 112 and second member 114 may be pivotally connected bya pivoting mechanism 120. The pivoting mechanism 120 may include apivoting opening 122 and a pivoting member 124. The pivoting member 124may be located on the first member 112 and the pivoting opening 122 maybe located on the second member 114. Alternatively, the pivoting member124 and pivoting opening 122 may be located on either the first member112 or the second member 114. Other pivoting mechanisms 120 may also beused. The pivoting member 124 of the present embodiment may include adetent configured to engage the pivoting opening 122.

The engaging element 110 may include a transitioning portion 130 with afirst transitioning dimension 132 a, in the open configuration shown inFIG. 1A, and a second transitioning dimension 132 b in the closedconfiguration shown in FIG. 1B. Transitioning dimensions 132 a, 132 bmay indicate distances between the first member 112 and the secondmember 114 in various configurations. The first transitioning dimension132 a may be smaller than the second transitioning dimension 132 b.

The engaging element 110 may include a first distal dimension 134 a inthe open configuration and a second distal dimension 134 b in the closedconfiguration. Distal dimensions 134 a, 134 b may indicate distancesbetween the first member 112 and the second member 114 in variousconfigurations. The first distal dimension 134 a may be larger than thesecond transitioning dimension 132 b.

The transitioning portion 130 may be configured to receive a distal endof the transitioning member 168. The transitioning member 168 mayinclude a transitioning surface 170 located near the distal end. Thetransitioning member 168 may be elongate and/or convex. Thetransitioning surface 170 may be operatively associated with thetransitioning portion 130 of the engaging element 110 to transition theengaging element 110 from the open configuration toward the closedconfiguration.

Referring to FIGS. 1A and 1B, transitioning the engaging element 110from the open configuration toward the closed configuration may includeexpanding the first transitioning dimension 132 a toward the secondtransitioning dimension 132 b. As the transitioning surface 170 of thetransitioning member 168 engages the transitioning portion 130 of theengaging element 110, the proximal ends of the first member 112 andsecond member 114 may expand away from each other. As the proximal endsexpand away from each other (from the open configuration), the tissueengaging portions 116 of the first member 112 and the second member 114may move toward each other (toward the closed configuration).

The engaging element 110 may include a locking mechanism 140 that may beconfigured to generally inhibit movement from the closed configurationtowards the open configuration. For example, as the proximal ends expandaway from each other, the locking mechanism 140 may inhibit movementback toward the open configuration.

The locking mechanism 140 may include a first locking portion 142 and asecond locking portion 144. The first locking portion 142 and the secondlocking portion 144 may be operatively associated. The first lockingportion 142 and/or the second locking portion 144 may be located nearthe proximal ends of the first member 112 and/or the second member 114,respectively. The first locking portion 142 may include at least onetooth. The at least one tooth may be configured to receive the secondlocking portion 144 which may include a locking member such as afollower. The locking member may be biased toward the at least onetooth. The use of multiple teeth may incrementally inhibit movementtoward the open configuration.

The pivoting opening 122 may include a retaining portion. The pivotingopening 122 may be configured to receive at least a portion of aretaining mechanism 166 on the retaining member 164 and the pivotingmember 124 of the engaging element 110. The pivoting opening 122 andretaining mechanism 166 may be operatively associated to limit movementof the engaging element 110 in at least one direction. For instance, thepivoting opening 122 and retaining mechanism 166 may limit motion of theengaging element 110 both longitudinally (i.e. through the retainingmember 164) and radially (i.e. about an axis within the retaining member164). The engaging element 110 may be inserted through the retainingmember 164 until the retaining mechanism 166 and the pivoting opening122 are retained. Alternatively, the retaining portion may be located onthe retaining member 164 while the retaining mechanism 166 is located onthe engaging element 110. Other retaining portion and/or retainingmechanism combinations, such as a detent and retaining groovecombination, may be used.

In order to align the pivoting opening 122 of the engaging element 110with the retaining mechanism 166 of the retaining member 164, theengaging element 110 may include an aligning portion 150, as shown inFIGS. 1A and 1B, which may be operatively associated with an aligningmechanism 167 of the retaining member 164. The aligning portion 150 ofthe engaging element 110 may include a ridge configured to be insertedinto the aligning mechanism 167 (i.e. a corresponding slot or groove) ofthe retaining member 164. In another embodiment, the aligning portion150 of the engaging element 110 may be a slot or groove configured toreceive the aligning mechanism 167, i.e. ridge, tab, etc., of theretaining member 164. In further embodiments, the aligning portion 150and/or the aligning mechanism 167 may take other forms to align theengaging element 110 with the retaining member 164 and/or transitioningmember 168.

Referring to FIGS. 2A-2F, the system 200 and engaging element 210 ofthis embodiment may be at least partially functionally similar to thatof the system 100 and engaging element 210 previously described aboveand shown in FIG. 1 in most respects, wherein certain features will notbe described in relation to this embodiment wherein those components mayfunction in the manner as described above and are hereby incorporatedinto this alternative embodiment described below. Like structures and/orcomponents are given like reference numerals.

The engaging element 210 may include a first member 212 and a secondmember 214. The first member 212 and the second member 214 may beconfigured to engage tissue. The tissue engaging portions 216 mayinclude tissue engaging portions 216 that may include a sharpened tip,barb, and/or other tip.

The first member 212 and second member 214 may be pivotally connected bya pivoting mechanism 220. The pivoting mechanism 220 may include apivoting opening 222 and a pivoting member 224. The pivoting opening 222may be located on the first member 212 and the pivoting member 224 maybe located on the second member 214.

The engaging element 210 may include a transitioning portion 230 with afirst transitioning dimension 232 a, in the open configuration shown inFIG. 2A, and a second transitioning dimension 232 b in the closedconfiguration shown in FIG. 2B. The first transitioning dimension 232 amay be larger than the second transitioning dimension 232 b.

The engaging element 210 may include a first distal dimension 234 a inthe open configuration and a second distal dimension 234 b in the closedconfiguration. The first distal dimension 134 a may be larger than thesecond transitioning dimension 232 b.

Referring to the system 200 shown in FIGS. 2C-2D, the engaging elementdelivery device 260 may include a transitioning member 268, a retainingmember 264, a carrier member 272, a locator 276, and/or othercomponents. The transitioning portion 230 of the engaging element 210may be configured to receive a distal end of the transitioning member268. The transitioning member 268 may include a transitioning surface270 located near the distal end that may be concave. The transitioningsurface 270 may be operatively associated with the transitioning portion230 of the engaging element 210 to transition the engaging element 210from the open configuration toward the closed configuration.

Referring to FIGS. 2C-2F, transitioning the engaging element 210 fromthe open configuration toward the closed configuration may includemoving the first transitioning dimension 232 a toward the secondtransitioning dimension 232 b. As the transitioning surface 270 of thetransitioning member 268 engages the transitioning portion 230 of theengaging element 210, the proximal ends of the first member 212 andsecond member 214 may move toward each other. As the proximal ends movetoward each other (from the open configuration), the tissue engagingportions 216 of the first member 212 and the second member 214 may alsomove toward each other (toward the closed configuration).

The engaging element 210 may include a locking mechanism 240 that may beconfigured to generally inhibit movement from the closed configurationtowards the open configuration. For example, as the proximal ends movetoward each other the locking mechanism 240 may inhibit movement towardthe open configuration.

The locking mechanism 240 may include a first locking portion 242 and asecond locking portion 244. The first locking portion 242 and the secondlocking portion 244 may be operatively associated. The first lockingportion 242 and/or the second locking portion 244 may be located nearthe proximal ends of the first member 212 and/or the second member 214,respectively. The first locking portion 242 may include a latch member.The latch member may be configured to engage the second locking portion244 which may include a latching portion. The latch member may be biasedto engage the latching portion. Although the latch member and latchingportion may be located on the first member 212 and the second member214, respectively, other locations may also be used. Furthermore,although a locking member and tooth combination and a latch member andlatching portion combination have been described, other lockingmechanisms may be used. For instance, a set of interlocking teeth may bedisposed on the first member 212 and the second member 214 similar tothe locking mechanism used for locking forceps.

The pivoting opening 222 may include a retaining portion that may beconfigured to receive a retaining mechanism 266 on the retaining member264. The pivoting opening 222 and retaining mechanism 266 may beoperatively associated to limit movement of the engaging element 210 inat least one direction.

The engaging element 210 of the present embodiment may include two typesof aligning portions 250 a, 250 b. The aligning portions 250 a near theproximal end of the engaging element 210 may be grooves configured toreceive an aligning mechanism 271 (i.e. a ridge) on the transitioningmember 268. The aligning portions 250 b near the tissue engagingportions 216 may be ridges configured to be inserted into a firstaligning mechanism 267, i.e. a corresponding slot or groove, of theretaining member 264. Other alignment portions 250 a, 250 b, alignmentmechanisms 267, 271, and/or configurations of the same (i.e. alignmentportions and/or alignment mechanisms on the engaging element 210,retaining member 264, transitioning member 268, and/or other components)may be used to orient the engaging element 210 relative to the engagingelement delivery device 260 such that the retaining member 264 mayretain the engaging element 210.

The transitioning member 268 may include a lumen that may receive acarrier member 272, a locator 276, and/or other components. The carriermember 272 may be configured to receive a locator 276 and/or othercomponents.

The transitioning member 268 may abut the transitioning portion 230 ofthe engaging element 210. The transitioning member 268 may include atransitioning surface 270 that is concave. As the transitioning member268 is advanced through the retaining member 264, the transitioningmember 268 may transition the engaging member 210 toward a closedconfiguration. The concave transitioning surface 270 may generally causethe proximal ends of the first member 212 and the second member 214 tomove toward each other. As the proximal ends of the first member 212 andthe second member 214 move toward each other, the tissue engagingportions 216 on the first member 212 and the second member 214 may movetoward each other.

FIGS. 3A-3K illustrate various steps in the deployment of an embodimentof an engaging element 310 to close a puncture according to one example.The systems 100, 200 and engaging elements 110, 210 discussed above inconnection with FIGS. 1A-1C and 2A-2F will now be discussed in thecontext of a patient and with respect to a blood vessel 390. The systems100, 200 and engaging elements 110, 210 may also be used with bodylumens other than blood vessels.

The system 300 and engaging element 310 of this embodiment may be atleast partially functionally similar to that of the systems 100, 200 andengaging elements 110, 210 previously described above and shown in FIGS.1 and 2 in most respects, wherein certain features will not be describedin relation to this embodiment wherein those components may function inthe manner as described above and are hereby incorporated into thisalternative embodiment described below. Like structures and/orcomponents are given like reference numerals.

The blood vessel 390 has a vessel wall 392 with an outer portion 392 aand an inner portion 392 b. The engaging element delivery device 360 maythen be used to apply the engaging element 310. In particular, a sheath380 may be inserted or otherwise positioned through skin 394 and tissue396 and within the blood vessel 390 or other body lumen via an opening398. The sheath 380 can include a substantially flexible or semi-rigidtubular member. Also, the sheath 380 can have a proximal end region 382a and a distal end region 382 b. The sheath 380 may further have apredetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension. The sheath 380 also can form a lumen384 that extends along a longitudinal axis of the sheath 380 andsubstantially between the proximal and distal end regions 382 a, 382 b.The lumen 384 can have any suitable internal cross-section and issuitable for receiving one or more devices (not shown), such as aguidewire 388, a catheter, and/or other devices.

The sheath 380 may be advanced over a guidewire 388 and/or other railthat may have been positioned through the opening 398 and into the bloodvessel 390 using conventional procedures. The blood vessel 390 can be aperipheral blood vessel, such as a femoral or carotid artery, althoughother body lumens may be accessed using the sheath 380. The opening 398,and consequently the sheath 380, may be oriented with respect to theblood vessel 390 such as to facilitate the introduction of devicesthrough the lumen 384 of the sheath 380 and into the blood vessel 390with minimal risk of damage to the blood vessel 390. One or more devices(not shown), such as a catheter, or the like, may be inserted throughthe sheath 380 and advanced to a preselected location within thepatient's body. For example, the devices may be used to perform atherapeutic and/or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patient'svasculature.

After the procedure is completed, the devices may be removed from thesheath 380. The engaging element delivery device 360 may be prepared tobe received by the lumen 384 of the sheath 380 as shown in FIG. 3B.Alternatively, the sheath 380 may be removed and then the engagingelement delivery device 360 may be positioned near the opening 398. Theengaging element delivery device 360 may include a retaining member 364,a transitioning member 368, a carrier member 372, a locator 376, and/orother components. The carrier member 372 may provide support for theengaging element 310. The locator 376 may be inserted through a channelin the carrier member 372.

The locator 376 may include a tubular body 378 having a distal endregion 379. Being in the unexpanded state, the distal end region 379 ofthe tubular body 378 of the locator 376 can be slidably received by thelumen 384 and atraumatically advanced distally into the blood vessel 390as illustrated in FIGS. 3B-3C. Advancing the distal end region 379 intothe lumen 384 begins the location of the locator 376 relative to theblood vessel 390.

Once the distal end region 379 of the tubular body 378 extends into theblood vessel 390, the distal end region 379 may transition from theunexpanded state to the expanded state as shown in FIG. 3D. A triggeringsystem (not shown) of the locator 376 may be used to transition from theunexpanded state to the expanded state. Locators other than theexpandable locator may also be used. For instance, a bleedback lumenand/or other locator may be used to locate the body lumen.Alternatively, no locator may be used. Rather, the engaging elementdelivery device 360 may be advanced until a technician determines thatthe distal end is near the opening.

Turning to FIG. 3E, the engaging element delivery device 360 and thesheath 380 may be retracted proximally until the distal end region 379is substantially adjacent to an inner surface 392 b of the blood vesselwall 392. The distal end region 379 thereby may draw the blood vesselwall 392 taut and/or may maintain the proper position of the system 300as the blood vessel 390 pulsates. Since the expanded cross-section ofthe distal end region 379 can be greater than or substantially equal tothe cross-section of the opening 398 and/or the cross-section of thelumen 384, the distal end region 379 may remain in the blood vessel 390and may engage the inner surface 392 b of the blood vessel wall 392. Thedistal end region 379 may frictionally engage the inner surface 392 b ofthe blood vessel wall 392, thereby securing the system 300 to the bloodvessel 390. The sheath 380 can be retracted proximally such that thedistal end region 382 b of the sheath 380 may be substantially withdrawnfrom the blood vessel 390, as shown in FIG. 3E, permitting system 300 toaccess the blood vessel wall 392.

Once the distal end region 379 of the locator 376 contacts the innersurface 392 b of the blood vessel wall 392, the engaging elementdelivery device 360 may be advanced distally and may be received withinthe lumen 384 of the sheath 380 as illustrated in FIG. 3F. The sheath380 may radially expand and/or split in accordance with thepredetermined pattern as the distal portion advances because theinternal cross-section of the sheath 380 may be less than an outerportion of the retaining member 364.

Upon reaching the first predetermined position, the distal portion ofthe retaining member 364 can be disposed substantially adjacent to theouter surface 392 a of the blood vessel wall 392 adjacent to the opening398 such that the blood vessel wall 392 adjacent to the opening 398 maybe disposed substantially between the expanded distal region 379 of thelocator 376 and the distal portion of the retaining member 364. Theengaging element 310 and retaining member 364 may be configured suchthat as the retaining member 364 approaches the distal end 379 of thelocator 376, the tissue engaging portions 316 of the engaging member 310may engage the outer portion 392 a of the vessel wall 392.

As shown in FIG. 3G, which is rotated ninety degrees to illustrate theinteraction of the first member 312 and second member 314 of theengaging element 310 during deployment, the transitioning member 368 mayadvance distally to cause the tissue engaging portions 316 of theengaging member 310 to move toward the closed configuration (i.e. fromthe first distal dimension to the second distal dimension). The convextransitioning surface 370 may cause the transitioning portion 330 of theengaging element 310 to transition toward the closed configuration (i.e.the proximal ends of the first member 312 and the second member 314 maymove away from each other while the tissue engaging portions 316 movetoward each other).

Alternatively, other transitioning members 368 and/or engaging elements310 may be used. For example, the transitioning member 268 and engagingelement 210 described in connection with FIGS. 2A-2D may be used, suchthat the concave transitioning surface 270 may cause the transitioningportion 230 of the engaging element 210 to transition toward the closedconfiguration (i.e. the proximal ends of the first member 212 and thesecond member 214 may move toward each other).

As the tissue engaging portions 316 move toward each other, the distalend 379 of the locator 376 may move toward the unexpanded configurationand/or begin to move proximally to allow the tissue engaging portions316 to fully engage the vessel wall 392. Alternatively, the locator 376may remain within the blood vessel 390 after the tissue engagingportions 316 have engaged the vessel wall 392 and/or may be laterremoved.

As shown in FIGS. 3H-3L, the engaging element 310 may be deployed. Theengaging element 310 may engage the vessel wall 392 (as shown in FIG.3F) in the open configuration. For instance, the tissue engagingportions 316 may frictionally, piercingly, and/or otherwise engage thevessel wall 392. As shown in FIG. 3I, the transitioning member 368 maycontinue to apply distal pressure to the engaging element 310 as theretaining member 364 begins to advance distally. The retaining member364 may begin to disengage from the engaging element 310. For example,the retaining mechanism 366 may begin to be removed from the pivotingopening 322 of the engaging element 310, as shown in FIG. 3I. Theretaining member 364 may be fully removed while the transitioning member368 maintains distal pressure on the engaging element 310, as shown inFIG. 3J. Then the remaining components of the system 300 may be removedthrough the skin 394, as shown in FIG. 3K. The engaging element 310 mayremain between the outer surface 392 a of the vessel wall 392 and theskin 394, i.e. within the tissue 396, while in the closed configuration.The opening 398 in the skin 394 may be closed with a bandage or otherdevice.

Access to the body lumen may be restablished by unlocking the lockingmechanism (140 shown in FIG. 1). For instance, a device (not shown) maybe used to push the locking member and/or latch member out of engagementwith the teeth and/or latching portion allowing the tissue engagingportions 316 to move away from each other toward the open configuration.

The invention is susceptible to various modifications and alternativemeans, and specific examples thereof have been shown by way of examplein the drawings and are herein described in detail. It should beunderstood, however, that the invention is not to be limited to theparticular devices or methods disclosed, but to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the claims.

I claim:
 1. An engaging element for engaging tissue, the engagingelement being configured to be delivered from a delivery device, theengaging element comprising: a first tissue engaging member thatincludes at least one tissue engaging portion at a first free end, thefirst tissue engaging member being movable between an open position anda closed position and having a second free end, the first tissueengaging member being restrained in movement at an intermediate positionbetween the first free end and the second free end; a second memberpositioned relative to and associated with the first tissue engagingmember, wherein the second free end and an end of the second member forma portion of a delivery-device receiving portion; and a lock portionoperatively associated with the first tissue engaging member, the lockportion maintaining a spacing between the first tissue engaging memberand the second member and inhibiting movement of the first tissueengaging member to the open position, the lock portion being operativelyassociated with a portion of the first tissue engaging member proximalthe intermediate position, wherein cooperation between the deliverydevice and the delivery-device receiving portion activates the lockportion and moves the first tissue engaging member toward the secondmember, the delivery-device receiving portion extending in alongitudinal direction with each of the second free end and the end ofthe second member comprising a curved inner surface to form a generallycircular opening when viewed in the longitudinal direction, thedelivery-device receiving portion being configured to receive and directthe delivery device longitudinally past the lock portion along alongitudinal axis of the delivery-device receiving portion, wherein, thelock portion is divided into a first lock assembly and a second lockassembly that are positioned on opposite sides of the delivery-devicereceiving portion in a direction transverse to the longitudinaldirection, each of the first lock assembly and the second lock assemblycomprises a first locking portion on the second member and a secondlocking portion extending from the first member and being biased towardsthe second member.
 2. The engaging element of claim 1, wherein the firsttissue engaging member is movable relative to the second member toengage the lock portion between the first tissue engaging member and thesecond member.
 3. The engaging element of claim 1, wherein one of thefirst tissue engaging member and the second member includes at least onerecessed portion that cooperates with another of the first tissueengaging member and the second member.
 4. The engaging element of claim1, wherein the lock portion allows transition of a distal end of thefirst tissue engaging member towards the closed position, the closedposition having a smaller cross-sectional dimension than the openposition.
 5. An engaging element for engaging tissue, the engagingelement being configured to be delivered from a delivery device, theengaging element comprising: a first member that comprises at least onetissue penetrating portion at a first free end and locking featurestowards a second free end, the first member being movable between anopen position and a closed position, the first member being restrainedin movement at an intermediate position between the first free end andthe second free end; a second member positioned relative to andassociated with the first member and comprising complementary lockingfeatures wherein the second free end and an end of the second memberform a portion of a delivery-device receiving portion; and wherein, thelocking features selectively maintain a spacing between the first memberand the second member and inhibit movement of the first member from theclosed position to the open position, the locking features beingoperatively associated with a portion of the first member proximal theintermediate position, wherein cooperation between the delivery deviceand the delivery-device receiving portion activates the locking featuresand the complementary locking features and moves the first tissueengaging member toward the second member, the delivery-device receivingportion extending in a longitudinal direction with each of the secondfree end and the end of the second member comprising a curved innersurface to form a generally circular opening when viewed in thelongitudinal direction, the delivery-device receiving portion beingconfigured to receive and direct the delivery device longitudinally pastthe locking features and the complementary locking features along alongitudinal axis of the delivery-device receiving portion, wherein, thelocking features are biased towards the complementary locking features,one locking feature and one complementary locking feature form a firstlock assembly and another locking feature and another complementarylocking feature form a second lock assembly, the first lock assembly andthe second lock assembly are positioned on opposite sides of thedelivery-device receiving portion in a direction transverse to thelongitudinal direction.
 6. The engaging element of claim 5, wherein thefirst member is movable relative to the second member to engage thelocking feature with the complementary locking feature.
 7. The engagingelement of claim 5, wherein one of the first member and the secondmember includes at least one recessed portion that cooperates withanother of the first member and the second member.
 8. The engagingelement of claim 5, wherein engagement of the locking feature and thecomplementary locking feature allow transition of a distal end of thefirst member towards the closed position, the closed position having asmaller cross-sectional dimension than the open position.
 9. An engagingelement for engaging tissue, the engaging element being configured to bedelivered from a distal end of a delivery device, the engaging elementcomprising: a first member that includes at least one tissue engagingportion and an end proximal the at least one tissue engaging portion,the first member being movable between an open position and a closedposition; a second member positioned relative to and associated with thefirst member, the end proximal the at least one tissue engaging portionand an end of the second member form a portion of a delivery-devicereceiving portion; and a slidable lock portion operatively associatedwith the first member, the slidable lock portion maintaining a spacingbetween the first member and the second member and inhibiting movementof the at least one tissue engaging portion to the open position, theslidable lock portion curving away from the at least one tissue engagingportion, wherein cooperation between the delivery device and thedelivery-device receiving portion activates the slidable lock portionand moves the at least one tissue engaging portion of the first membertoward the second member, the delivery-device receiving portionextending in a longitudinal direction with each of the end of the firstmember and the end of the second member comprising a curved innersurface to form a generally circular opening when viewed in thelongitudinal direction, the delivery-device receiving portion beingconfigured to receive and direct the delivery device longitudinally pastthe slidable lock portion along a longitudinal axis of thedelivery-device receiving portion, wherein, the slidable lock portion isdivided into a first lock assembly and a second lock assembly that arepositioned on opposite sides of the delivery-device receiving portion ina direction transverse to the longitudinal direction, each of the firstlock assembly and the second lock assembly comprises a first lockingportion on the second member and a second locking portion extending fromthe first member and being biased towards the second member.
 10. Theengaging element of claim 9, wherein the first member and the secondmember pivotally cooperate.
 11. The engaging element of claim 9, whereinone of the first locking portion and the second locking portion includesat least one tooth that cooperates with the other of the first lockingportion and the second locking portion.
 12. The engaging element ofclaim 9, wherein sliding of a portion of the slidable lock portiontransitions a distal end of the first member towards the closedposition, the closed position having a smaller cross-sectional dimensionthan the open position.